Pharmaceutical Quality Systems

We are specialized in assisting clients by providing expertise, on site support and on site training courses covering implementation and optimization of Pharmaceutical Quality Systems according to FDA, EU GMP, ICH and PIC/S.
Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.Read More

Change Management - Establish and Maintain a State of Control

Innovation, continual improvement, the outputs of process performance and product quality monitoring and CAPA drive change. In order to evaluate, approve and implement these changes properly, a company should have an effective change management system.
The change management system ensures continual improvement is undertaken in a timely and effective manner. It should provide a high degree of assurance there are no unintended consequences of the change.Read More

Enablers: Knowledge Management and Quality Risk Management

Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. Quality risk management can be useful in identifying the monitoring and control systems.Read More

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TAKE A LOOK AT OUR SERVICES

We are specialized in assisting clients by providing expertise, on site support and on site training courses covering implementation and optimization of Quality Systems according to FDA, EU GMP and PIC/S with emphasis on:

Risk Management & risk-based GMP interpretation

Inspection Preparation (FDA, National Authorities)

Batch Release and QP Services

CAPA and Deviation / Complaint Handling

Supplier Quality Assessment and Auditing

Operational Excellence

DR. BERND RENGER

Dr. Bernd Renger has more than 35 years industry experience in different managing positions in API Manufacturing and Pharmaceutical Industry. He started his professional career with Hoechst AG as a Research and Development Chemist.

Since than, he has held positions as Director of Quality Control and/or Quality Assurance at Mundipharma (Limburg), Byk Gulden/Altana Pharma (Singen), Baxter BioScience (Vienna) and Vetter Pharma Fertigung (Ravensburg).

He holds a degree in Organic Chemistry from the University in Giessen, Germany and is an appointed Qualified Person according to the European regulations and has acted as a Qualified Person in the EU for more than 27 years. He is an expert in Quality Systems and Quality Risk Management System design, development and implementation.

Dr. Bernd Renger

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SUBJECT MATTER EXPERT

Bernd Renger has been Member of:

The Expert Group "Pharmaceutical Analysis/Quality Control" of the German Pharmaceutical Society

The Advisory Board of the European Compliance Academy (ECA)

The Advisory Board and Chairman of the European Qualified Person (QP) Association; www.qp-association.eu (external link)

He is author or co-author of more than 80 publications and is a frequently invited speaker by organizations such as PDA, Advanstar, IBC, IIR, Forum, PCS, European Compliance Academy and Concept Heidelberg at more than 150 events or training courses covering: